For years, there have been countless trends and new products to emerge to help minimize or cure acne. From the Ancient Egyptians using sulfur to individuals today using over the counter products, the “perfect” cure for acne has yet to be discovered. However, in 1982, Roche Pharmaceuticals developed what they thought would be the cure all for cystic acne. Little did they known that this drug, called Accutane, would effect millions of individuals in a negative way still to this day.
While Accutane manufacturer Roche Pharmaceuticals lost its patent in the early 2000s and stopped manufacturing the drug in the USA in the summer of 2009 because of the number of adverse events reported to the FDA and lawsuits from patients rapidly growing, it is still affecting millions today. Today, many still suffer from its side effects years later, especially those who were not aware of the drug’s downfalls in the 1980s. Even when it was discovered to have negative health benefits, the drug was still of interest to many. Dr. Iris Dubetsky, a dermatologist at the Dermatology Associates of Central NJ, has a first hand account of the devastating effects Accutane can bring as well as recent news of individuals still trying to obtain the drug’s generic copies.
To briefly describe its history, Accutane was developed in 1982 by to treat moderate to severe acne that other medications could not effectively treat. The drug is a form of vitamin A, which had been known and used in the past in other forms to treat acne. By 1983, the drug was celebrated and viewed as revolutionary in the medical industry and the doctor behind it all, Dr. Peck, received multiple awards from the U.S. Public Heath Services and the Department of Commerce. Like any drug, it did have its side effects, however the extent of severity of these side effects was still unknown. As studies began to emerge from the late 1980s to the early 2000s, the severity of the drug’s side effects became more apparent.
The first study to emerge about Accutane that questioned its safety was one that looked at pregnancy and birth defects. While it was known that the drug could potentially be harmful to those who were or were to become pregnant while taking the drug, there were no studies or research to confirm this. However, in the late 1980s, more research came out and this was the first major blow to the downfall of Accutane. According to the FDA, the drug was directly linked to causing heart and brain defects as well as an abundance of developmental disorders in fetuses.
Before becoming a dermatologist, in the 1980s Dr. Iris Dubetsky was your normal and average teenager and her sister was your average woman in her 20s however she suffered from terrible acne. “Since I could remember, my sister always suffered from acne and tried just about everything she could to cure it. So when Accutane came along, it was like an answer to her prayers.” Her sister immediately requested to be put on the drug and over an extended period of time, it began to cure her acne. After taking the drug for about 8 months, she became pregnant. “She knew that there was talk that Accutane could cause birth defects but there were no real studies to back this up she didn’t think twice about possibly being in harms way.” Three months into her pregnancy, she found out the heart breaking news that her baby was not developing properly, and it was most likely due to her use of Accutane. About a month later, she had sadly lost the baby in a spontaneous miscarriage. “We were all devastated. It was a traumatic experience and to think that it all could have been prevented.” She was not only because from 1983 to 2003, there are a total of 2000 other woman having gotten pregnant while on Accutane, most of them having either miscarried or had children born with birth defects.
As time continued, more studies were being conducted on Accutane and more side effects emerged. The FDA, these include: reported hair loss, sensitivity to the sun (which increases the risk of skin cancer), severe depression and thoughts of suicide. Before being pulled from the market, the FDA issued a black box warning be put on Accutane, which is the highest possible warning that can be issued.
With losing its patent, this opened the door for other companies and manufacturers to create generic versions of Accutane, many of which are just as harmful. Dr. Dubetsky also stated that in recent months, she has seen a handful of patients who are obtaining these generic brands. “Accutane was pulled [from the market] for a reason. I have my own personal views on it but research backs up the dangers of the drug.” While she could not go into much detail about it, her patients have seen some of the same side effects Accutane causes, like depression and skin cancer scares.
What was once viewed as a revolutionary drug, Accutane quickly fell out of favor for doctors as well as patients. It was thought to be the cure all drug for acne but the negatives outweighed the positives. Today, millions of individuals are said to have suffered or still suffer from the drugs severe and sometimes deadly side effects like Crohn’s disease, birth defects like learning and mental disabilities as well as on going depression. In fact, from 1982 to May 2000, the FDA received hundreds of reports linking Accutane use to depression, including 37 suicides, 110 hospitalizations for depression or suicidal behavior, and 284 cases of non-hospitalized depression. In closing, Dr. Dubetsky stated: “It is scary to see individuals still trying to obtain the drug, even after being pulled from the US market and all the issues it can cause. It is my hope that any form of the drug be discontinued but until then, all I can do it educate my patients of the harm it causes and wait for the day to it disappear [from the market] completely.”